Tuesday, December 02, 2014

U.S. House Members Urge FDA to Change Grandfather Date in Proposed Deeming Regulations

Speaker of the House John Boehner, along with the House Majority Leader Kevin McCarthy and Chair of the Energy and Commerce Committee Fred Upton, have sent a letter to the FDA and Center for Tobacco Products urging that the proposed deeming regulations be changed. Specifically, they have requested that the FDA change the grandfather date of February 15, 2007 to either April 25, 2014 (the date the deeming regulation was published) or to the effective date of the final deeming regulation.

The representatives' concern is that with the proposed grandfather date, it will be virtually impossible for current electronic cigarette products to claim substantial equivalence to a predicate product. Therefore, virtually every electronic cigarette company will need to file a new product application, which is a burdensome and expensive undertaking. The net result could be the removal of thousands of electronic cigarette products from the market.

The letter asks the FDA to change the grandfather date "to ensure that these innovative
products are not snuffed out by overly burdensome regulations."

According to the letter: "As a practical matter, many newly
deemed products could be removed from the market. ... [T]he cost and barriers
surrounding a new product submission would largely prevent new entries, posing
an unwarranted regulatory barrier to innovation. ... This is a critical issue, and we request
that manufacturers of newly deemed tobacco products have the same market entry
opportunities as manufacturers of cigarettes and other currently regulated
tobacco products. ... Any final provision on this issue should ensure equity
among all regulated tobacco products and encourage innovation while achieving
the purpose of the law."

The Rest of the Story

I agree with the request that is being made in this letter. However, I would go further and recommend that the FDA not require new product applications for any products. Doing so stifles innovation and makes it difficult if not impossible for newer products that may be safer and more effective to enter the market.

These comments are similar to those expressed by Altria Client Services, Lorillard, and the American E-Liquid Manufacturing Standards Association.

They also echo my initial comments about the proposed deeming regulations, when I wrote:

"This provision is going to present a huge obstacle to innovation in this
category. The newer products tend to be safer and more effective, so it
makes no sense to allow the older products to remain on the market
while requiring pre-approval for the newer and better products. The
implications of this regulation is going to depend on the evidence that
the agency requires to approve these applications. A stringent
interpretation of the regulations will put a huge dent in electronic
cigarette innovation and could limit the expansion of the market. In
addition, this provision is going to place an undue burden on smaller
companies and give a huge advantage to larger companies, including the
tobacco companies that have entered the e-cigarette market."

"The regulations require pre-approval
or substantial equivalence determinations of almost all existing
electronic cigarette products."

"This provision is going to wreak havoc with the industry. The agency is
determined that it cannot extend the grandfather date beyond 2007. This
means that any product not on the market as of 2007 (which includes
almost all electronic cigarette products) must either obtain a new
product approval or a substantial equivalence determination. Given the
snail's pace at which the FDA has processed cigarette substantial
equivalence determinations, this could result in a literal quagmire of
pending applications for the more than 250 brands of e-cigarettes
currently on the market."

(Thanks to Greg Conley for the tip.)

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.